510(k) · Cleared
ClearedAtlasplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on May 18, 1998 as substantially equivalent to K894263 (Medical Instrumentation & Diagnostics Corp.(Midco), 1989) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- May 18, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894263 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K013861Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894263 | Cass System | Medical Instrumentation & Diagnostics Corp.(Midco) | 1989 | — |
| 0 (this device) | K980584 | Atlasplan | Radionics, Inc. | 1998 | — |
| +1 | K013861 | Modification to Leksell Surgiplan with Atlaspace | Elekta Instrument AB | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K894263 | Cass SystemSummary page 1…unction with neurosurgery, radiotherapy, and radiosurgery planning systems. Predicate Device: Medical Instrumentation and Diagnostics Corporation (MIDCO) cass System (#K894263A, 9/1/89; #K911750, 10/15/91; #K921740,4/7/93) Establishment Name and Radionics Software Applications, Inc. Address: 22 Terry… | 1989 |
| * | K911750 | Computer Assist Stereotactic Surg Syst, ModifiedSummary page 1…urgery, radiotherapy, and radiosurgery planning systems. Predicate Device: Medical Instrumentation and Diagnostics Corporation (MIDCO) cass System (#K894263A, 9/1/89; #K911750, 10/15/91; #K921740,4/7/93) Establishment Name and Radionics Software Applications, Inc. Address: 22 Terry Avenue Burlington,… | 1991 |
| * | K921740 | Computer Assisted Stereotactic Surgery -- ModifiedSummary page 1…, and radiosurgery planning systems. Predicate Device: Medical Instrumentation and Diagnostics Corporation (MIDCO) cass System (#K894263A, 9/1/89; #K911750, 10/15/91; #K921740,4/7/93) Establishment Name and Radionics Software Applications, Inc. Address: 22 Terry Avenue Burlington, MA 01803 Contact Na… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013861 | Modification to Leksell Surgiplan with Atlaspace | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K013861 (Elekta Instrument AB, 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
AtlasPlan is intended to be used for pre- and intra-operative planning of stereotactic procedures. This software module correlates a patient's anatomy (obtained from CT or MRI scans) with an anatomical atlas of the brain. AtlasPlan may be used alone or in conjunction with neurosurgery, radiotherapy, and radiosurgery planning systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980584: Atlasplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980584
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026